Michael Amar Email

Internationnal regulatory affairs @ Rafa Laboratories

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Michael Amar Location

Israel

Michael Amar Work

2020 - now Internationnal regulatory affairs @
2015 - 2019 R and D Project Manager @
2015 - 2019 Stemcell Medicine Ltd. Responsible Pharmacist QP and Regulatory Affairs Pharmacist @
2014 - 2015 Regulatory Affairs, Deputy QP and Deputy QP PV Pharmacist @
1998 - 2012 R and D Project Manager and Responsible Pharmacist @
1996 - 1998 Pharmacist @ Superpharm
1995 - 1995 Pharmacy school 6th year and DEA (a postgraduate degree granted 5 years @ Structural Biology & Protein Engineering dep, National Scientific Research Cente

Michael Amar Education

Israeli Health Ministry Pharmacists Licence exam
Pharmacists Licence
2013 - 1996
Oulpan Etsion Jerusalem
(Hebrew intensive courses)
1996 - 1996
University Paul Sabatier Toulouse III
Master with These (Molecular modeling)
1993 - 1995
University Paul Sabatier Toulouse III
State Diploma of Doctor in Pharmacy (Industry and Research specialization)
1988 - 1995
Fermat high school in Toulouse 1987 - 1988
Israeli Health Ministry
Appointed Pharmacist approval, based on previous working experience
2013null
High School Muret
High School Diploma (Mathematics & Physics)
2013null
Israeli Health Ministry 2013null

Michael Amar Skills

14 years experience in Generic drugs formulation development
Scale up and process validation
CTD format Registration file redaction according to EU and IL guides
Submission strategy determination and answer to defficiency letters
Familiar with JV with Eueopean generic companies like STADA GmbH
9 years experienced Responsible Pharamcist exempted from QP courses
Pharmacist diplomed from France (EU) able to be QP for EU
French: mother tongue
English: working knowledge
French
V&V
Determination
Redaction
English
Generic Drugs
Regulatory Affairs
Formulation
Pharmaceutical Industry
FDA
Regulatory Submissions
CAPA
Generic Programming
Validation
R&D
GMP

Michael Amar Summary

Michael Amar, based in Israel, is currently a Internationnal regulatory affairs at Rafa Laboratories. Michael Amar brings experience from previous roles at Mapi Pharma, Tec-O-Pharm Group and Dexcel Pharma. Michael Amar holds a 2013 - 1996 Pharmacists Licence @ Israeli Health Ministry Pharmacists Licence exam. With a robust skill set that includes 14 years experience in Generic drugs formulation development, Scale up and process validation, CTD format Registration file redaction according to EU and IL guides, Submission strategy determination and answer to defficiency letters, Familiar with JV with Eueopean generic companies like STADA GmbH and more. Michael Amar has 3 emails on RocketReach.

Michael Amar Emails

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